Maruthi Kumar A
Bangalore
Summary
Versatile executive with 11.6- year track record of overseeing & managing technical operations to achieve business objectives. Strong knowledge of QMS, Product management, and key decision making. A disciplined and forward-thinking executive with excellent communication and team-building skills.
Overview
12
12
years of professional experience
Work History
Technical Writer-Quality & Compliance
Virtuous Transactional Analytics Pvt. Ltd
Whitefield
02.2023 - Current
- Collaborating and providing QMS inputs and documentation support to New Product teams, including developing/refining technical and process documentation.
- Reviewing SDLC deliverables to ensure compliance with QMS.
- Manage documentation workflows and schedules and proofread drafts for adherence to established document design and internal Quality Management System standards.
- As a key member in Product Management team, primary link between stakeholders & teams evaluating product documentation progress.
- Experience in handling Microsoft applications & basic knowledge on Jira tool.
- Participating in continuous process improvement and stakeholder management.
- Supporting to Quality Head and Product teams during customer Audits.
- Schedule and lead discussions around needed documentation changes with different team (product development, product quality & architecture teams).
- Ensuring proper grammar, consistency & proofing of all documents.
- Handling trainings to new team members and for existing team members any changes in QMS as wand when needed.
- Project Management knowledge with technical documentation review.
Team Lead-Quality Excellence
Medi Assist Health Care Pvt. Ltd
Bannerghatta Road
07.2022 - 01.2023
- Conduct quality check on final documents (such as User Manuals, SOP, Work Instructions, Release notes, etc.) prior to deliver for content, formatting consistency and grammar.
- Assist with development/maintenance of web-based documentation, training and support materials.
- Prepare, Edit, standardize or make changes to material prepared by other writers or other team members & maintaining Good Documentation Practices (GDP).
- Analyse current documents and make necessary improvements to align with corporate style guide and team standards for document consistency.
- Participate in the layout and design of the document, with reference to diagrams that support the step-by-step instructions by using web-based applications.
- Partner with development teams and training teams to create, customize and complete new and existing documentation projects within assigned timelines.
- TPA Organization
Senior Executive- Quality Assurance
Kemwell Biopharma Pvt. Ltd
Bangalore
08.2020 - 07.2022
- Preparation and review of SOPs, STPs, Specifications and other associated Bio-Analytical documents as per GDP pertaining to Quality control and Microbiology.
- Managing LIMS software as a QA Reviewer- (Review and Approval) of Test plan, Worksheets, TDTC, Specifications, Sample login status, COA, User Privileges & User profile verification, Stability data in Production (PLANT) and MASTERS LIMS.
- Review of executed documents including Batch analytical records (Finished product, In process, Stability), microbiological data and other associated records (equipment usage, column usage logbooks) through LIMS wherever applicable.
- Stability study protocols, reports, Stability data compilation reports and Equipment qualification documents review & approval.
- Performing routine Lab Surveillance in accordance with internal procedures and GLP requirements.
- Performing Audit trail review for all Bioanalytical equipment's in Lab and software (LIMS-CALIBER-v3.5.0E), & preparation & review of COC before batch release to maintain Data integrity and Compliance.
- Coordination with cross functional teams for planning timely review and release of Raw materials & COA.
- Audit trail Review of Empower 3_HPLC CDS, Temperature Excursions for deep freezers, stability chambers through Newtronics-ICDAS SCADA software to ensure all the testing are in compliance with 21 CFR Part 11 & ALCOA+ principles.
- Handling & Review of Change control, Deviations & CAPA, support in QMS elements (OOS/OOT/Atypical) & trends preparation as per requirement and on-time completion of trainings in eLMS.
- Performing Visual inspection of microbial media filled vials, pre-filled vials for sterility.
Senior Executive - QC-Compliance
Anthem Biosciences Pvt. Ltd
Bangalore
11.2017 - 03.2020
- Responsible for review of complete Analytical Data Package against approved Specifications also against electronic data generated by the system.
- Performing of Audit Trails review of all Instruments/Software's electronic data.
- Review of Working Standards, Impurity Standards and Certificate of Analysis.
- Review & Preparation of SOP, Protocols & COA for quality requirement and initiation of Change Control Form (CCF) & its approval from QA.
- Participating in QMS Activities & in Preparation of Incidents trending activities.
- Review of all Analytical instrument usage Log Books, Column Usage Log Books, Draft Reports, Equipment Cleaning documents for Compliance & Data integrity.
- HPLC/GC Column inventory management of both QC and ARD Departments.
- Lab Surveillance and Audit support activities.
GVK Biosciences Pvt. Ltd
Bangalore
09.2015 - 09.2017
- Company Overview: Client location-Apotex pharma Ltd. ARPL
- Review of Analytical data using Sophisticated (Empower 3-HPLC CDS), LABWARE-LIMS (v6 and v7) & general purpose (MS Excel) Software.
- Identifying and discovering the OOS/OOT's from the analysis results standard protocols along with investigation reports from LIMS.
- Review of Calibration and Qualification records of lab instruments.
- Review of various documents like SOP's, formats, stability/validation protocols, Equipment Cleaning reports, validation reports, specifications, analytical reports.
- Client location-Apotex pharma Ltd. ARPL
Bureau Veritas Pvt Ltd
Hyderabad
01.2013 - 02.2015
- Instrumental analysis of all products as per pre-set parameters as well as calibration.
- Wet lab analysis of all types of Water, Soil & Food Samples by instrumental, gravimetric & Titrimetry as per ISO/IEC-17025:2005 QMS.
- Heavy Metal Analysis by Wet Digestion & Microwave Digestion through ICP-MS, Empower-CDS and AAS instruments. Interpretation of Analytical Test Results and batch Creation in LIMS software.
Education
Master of Science - BioChemistry
Pratibha P.G College
HyderabadBachelor of Science - Biotechnology, Microbiology, Chemistry
SV Degree & P.G College
AnantapurAssociate of Science - Bi.P.C
Board of Intermediate Education A.P
KadiriS.S.C -
Board of Secondary School A.P
KadiriSkills
- MS Office
- Quality Assurance
- Trackwise Digital
- Quality Reviewer
- Quality Management
- Technical writing
- LIMS software
- Computerized system validation (CSV)
- Document control
- Veeva Systems
- Empower Software
- Stakeholder Management
Awards And Conferences
- Achieved an award in 12th Standard with Town 2nd Prize in 2006.
- Achieved an award in Essay Writing Competition, with a 2nd Prize at the district level in 2006.
Languages
- Telugu
- English
- Hindi
- Kannada (beginner)
Personal Information
- Sex: Male
- Date of Birth: 03/24/1988
- Nationality: Indian
- Marital Status: Single
- Hobbies: Photography and Travelling
Languages
Telugu
First Language
English
Upper Intermediate (B2)
B2
Hindi
Intermediate (B1)
B1
Kannada
Beginner
A1
Disclaimer
I deem it a privilege to been Employee of your firm. I assure you that if appointed I will do my best to rise to the expectation of my superior.
Place
Bangalore, Karnataka
Timeline
Technical Writer-Quality & Compliance
Virtuous Transactional Analytics Pvt. Ltd
02.2023 - Current
Team Lead-Quality Excellence
Medi Assist Health Care Pvt. Ltd
07.2022 - 01.2023
Senior Executive- Quality Assurance
Kemwell Biopharma Pvt. Ltd
08.2020 - 07.2022
Senior Executive - QC-Compliance
Anthem Biosciences Pvt. Ltd
11.2017 - 03.2020
GVK Biosciences Pvt. Ltd
09.2015 - 09.2017
Bureau Veritas Pvt Ltd
01.2013 - 02.2015
Master of Science - BioChemistry
Pratibha P.G College
Bachelor of Science - Biotechnology, Microbiology, Chemistry
SV Degree & P.G College
Associate of Science - Bi.P.C
Board of Intermediate Education A.P
S.S.C -
Board of Secondary School A.P
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